J Korean Soc Transplant.  1999 Dec;13(2):195-202.

Efficacy of Tacrolimus in Primary Kidney Transplant Patients: Multi-center, Open-label, Prospective Study

• Park K
• Kang CM
• Koh YB
• Kwak JY
• Kwon OJ
• Kim SJ
• Kim SI
• Kim YS
• Kim YS
• Moon IS
• Moon JI
• Bang BK
• Ahn C

Abstract

Introduction of tacrolimus has been accepted as one of the major advance in the management of rejection following solid organ transplantation. This open-label, multi-center study is designed to confirm the efficacy of tacrolimus in primary kidney transplantation. A total of 64 renal transplant recipients were recruited from 4 medical centers, and received dual drug therapy consists of tacrolimus and low-dose corticosteroids after kidney transplantation. Tacrolimus was started 2 days prior to the transplantation with the dosage of 0.2 mg/kg/day. Daily dose of tacrolimus was modulated to maintain the trough blood level between 15 ng/ml and 20 ng/ml for the first 3 months and between 10 ng/ml and 15 ng/ml for the next 3 months after the transplantation. Steroid pulse therapy with methylprednisolone was used as a first line modality of acute rejection treatment. Steroid resistant rejection was treated with anti- lymphocyte agents. Post-transplant diabetes mellitus was defined as the cases when patients who had no history of glucose intolerance need the use of oral hypoglycemics and/or insulin for 30 days or longer to control their hyperglycemia after transplantation. There were 51 live donor and 13 cadaveric donor transplantations. Live donor transplantation consisted with 33 related (10 HLA identical, 23 HLA haplo- identical) and 18 unrelated pairs. Mean age of the patients was 39.4 9.6 (range; 22-58). There were 36 male and 28 female patients. There were 21 acute rejection episodes in 17 patients (26.6%) during the first 6 months after transplantation. Six patients were treated with anti-lymphocyte agents, and 4 patients showed complete response but 2 episodes (9.5%) showed partial rescue. Six-month patient and graft survivals were 100% and 98.4%, respectively. A total of 18 patients (28.1%) experienced glucose intolerance during the study period. Tacrolimus showed satisfactory efficacy in primary kidney transplantation. Long-term follow up is needed for further evaluation of efficacy and safety.

Keyword

Tacrolimus; Primary kidney transplantation; Efficacy and safety

MeSH Terms

Adrenal Cortex Hormones
Cadaver
Diabetes Mellitus
Drug Therapy
Female
Follow-Up Studies
Glucose Intolerance
Graft Survival
Humans
Hyperglycemia
Hypoglycemic Agents
Insulin
Kidney Transplantation
Kidney*
Lymphocytes
Male
Methylprednisolone
Organ Transplantation
Prospective Studies*
Tacrolimus*
Tissue Donors
Transplantation
Transplants
Adrenal Cortex Hormones
Hypoglycemic Agents
Insulin
Methylprednisolone
Tacrolimus